Treatment of Antibody-Mediated Rejection (ABMR) With CarBel

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients who are experiencing kidney transplant rejection, known as Antibody-Mediated Rejection (ABMR). The study will test two medications, carfilzomib and belatacept, to see if they can safely improve kidney function when added to the standard medications that transplant patients usually take. Researchers want to find out if these drugs can reduce the harmful antibodies against the transplanted kidney and if they affect the immune cells involved in the rejection process. Additionally, they will explore whether new computer techniques can help identify important changes in kidney biopsies, which are tests that check for damage.

To be eligible for this trial, participants must have had a kidney transplant and have specific types of kidney rejection. They should also agree to use birth control during the study and have good heart function. Patients will need to be at least 18 years old and meet certain health requirements, such as having a specific kidney function level. If you decide to participate, you will be closely monitored throughout the study with blood and urine tests to check your kidney health and overall well-being. This trial is not yet recruiting, so more information will be available when it officially begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to understand and agree to participate in the study.
• • 2. Have received a kidney transplant from a living or deceased donor (including re-transplants).
• • 3. Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal.
• • 4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.
• • 5. Must have been previously exposed to the Epstein-Barr Virus (EBV).
• • 6. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.
• • 7. Kidney function must be at a certain level (eGFR of at least 30 ml/min/1.73 m²).
• • 8. Specific scores related to kidney biopsy results must be within certain limits.
• • 9. Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity.
• • 10. Up-to-date vaccinations according to guidelines for transplant patients.
• • 11. Must have a negative tuberculosis (TB) test and chest x-ray before enrollment, no symptoms or known contact with TB, and not have recently traveled to or lived in areas with high TB rates. If previously infected with TB, must have completed treatment and have a recent negative chest x-ray.
• • 12. If previously infected with COVID-19, must be fully recovered for at least 21 days before joining the study. No COVID-19 test required for those without symptoms.
• Exclusion Criteria:
• • 1. Unable or unwilling to give consent or follow study rules.
• • 2. Kidney transplant with incompatible blood types.
• • 3. Very high levels of protein in urine, indicating severe kidney issues.
• • 4. Previously had a non-kidney organ or bone marrow transplant.
• • 5. Any other medical issues that might increase risk, make following the study rules hard, or affect study results, as judged by the study doctor.
• • 6. Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.
• • 7. Severe heart failure (Class 3 or higher).
• • 8. Irregular heartbeats that can't be controlled with medication.
• • 9. Used any experimental drug within the last 4 weeks or longer if the drug stays in the body longer.
• • 10. Serious medical or mental health issues that could interfere with the study.
• • 11. Cancer diagnosis or treatment within the past 2 years, except for certain skin cancers or cancers with a high cure rate.
• • 12. Known allergy to Captisol® (used in the study drug).
• • 13. Very low blood counts (hemoglobin, neutrophils, or platelets).
• • 14. Positive for HIV, Hepatitis B, or Hepatitis C, unless Hepatitis C was successfully treated.
• • 15. Severe infections needing treatment in the last 4 weeks.
• • 16. Specific kidney infection (BK nephropathy) or high levels of BK virus.
• • 17. Certain kidney biopsy results indicating other types of rejection or kidney diseases.
• • 18. Treated for a specific viral infection (CMV) in the last 90 days or resistant to certain CMV treatments.
• • 19. Received a live vaccine in the last 4 weeks.
• • 20. Severe liver disease or abnormal liver tests.
• • 21. Pregnant or breastfeeding women. Women who can become pregnant must have a negative pregnancy test or proof they are not pregnant.
• • 22. Any other significant medical condition that could interfere with the study according to the doctor.
• • 23. Received certain antibody treatments in the last 3 months.
• • 24. Kidney rejection within 6 months post-transplant without standard care.
• • 25. Confirmed severe protein levels in urine.
• • 26. Underwent certain treatments outside study criteria.
• • 27. History of multiple unprovoked blood clots.
• • 28. Diagnosed with Atypical Hemolytic Uremic Syndrome (aHUS).